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-LY2940680

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Jul 22, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01746745A Study of LY2940680 in Healthy ParticipantsPHASE1 COMPLETED 6 — — Jan 1, 2013Mar 1, 2013Jul 22, 20191 United States
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Study Endpoints
Primary Endpoints
Fecal Excretion of LY2940680 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Predose up to 14 days postdose. Samples collected at 24-h intervals.

The percentage of the total radioactive dose administered that was excreted in feces = \[(amount of radioactivity recovered in feces)/(radioactive dose administered)\]\*100.

Urinary Excretion of LY2940680 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Predose up to 14 days postdose. Samples collected at 6-h intervals on Day 1 (0-6, 6-12, and 12-24 h postdose) and at 24-h intervals thereafter.

The percentage of the total radioactive dose administered that was excreted in urine=\[(amount of radioactivity recovered in urine)/(radioactive dose administered)\]\*100.

Secondary Endpoints
Plasma PK of LY2940680 and LSN3185556: Maximum Observed Concentration (Cmax)
Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter
PK of Radioactivity: Cmax
Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter.
PK of LY2940680, LSN3185556, and Radioactivity: Time of Maximum Observed Concentration (Tmax)
Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
[^14C]-LY2940680EXPERIMENTALSingle 100 milligram (mg) dose of LY2940680 containing 100 microCuries of carbon-14-labeled LY2940680 (\[\^14C\]-LY2940680)
Interventions
NameTypeDescription
[^14C]-LY2940680DRUGAdministered as solution by mouth
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Generally healthy sterile males or surgically sterile females or postmenopausal females, as determined by medical history and laboratory assessments * Have a body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m\^2), inclusive Exclusion Criteria: * Regularly...

Countries:United States
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